REAL-TIME PCRGenomic and Molecular Services
REAL TIME PCR
Real-time PCR remains one of the most sensitive and quantitative tools for gene expression used today. MOgene offers both custom and pre-optimized QPCR assays for a wide variety of applications such as gene (mRNA, microRNA and non-coding RNA) expression, genetic variation (SNP genotyping, DME genotyping or Copy Number Variation) analysis, mutation detection analysis, and epigenetic analysis in “RUO” or “regulated” projects. We manage all aspects of the project from assay design, to nucleic acid isolation, to data analysis.
QuantStudio 12k Flex OpenArray system
Utilizing ABI’s QuantStudio 12k Flex Real-Time PCR system MOgene has the capability of running hundreds of real-time PCR reactions simultaneously. This flexible system allows us to provide you a collection of different configurations to match your requirements.
SERVICE FEATURES AND OPTIONS
- qPCR primer and probe design
- Nucleic acid isolation from tissue, cells, biotechnology products, etc.
- Quantitation using a NanoDrop® ND-1000
- Qualitative analysis by an Agilent BioAnalyzer®
- Primer/Probe optimization
- Samples assayed in duplicate to ensure reproducibility
- Controls included on each thermocycling run
- Data report with project design description
- Statistical analysis upon request
Quality and safety
The Quality Commitment From MOgene
MOgene has a state-of-the-art CLIA certified facility with an established reputation of complying with relevant national and international GxP compliance regulations.
- CLIA Regulations 42 CFR Part 493, cGMP compliance per FDA 21 CFR Part 210/211, GLP compliance per FDA 21 CFR Part 58 and Part 11
- Active CAPA program for process improvement
- Audit ready for clients with routine internal quality audits
- Assays validated per ICH/CLSI guidelines
- CLIA Certification
- USDA Certification
Quality Management System
MOgene has a robust Quality Management System (QMS) detailed in a Quality Manual that details the quality policy of MOgene along with a set of quality procedures that outline the necessary documented controls and compliance measures to ensure continual quality monitoring and improvement.
- Rigorous sample management process
- Transparent and routine communications on project timelines and deliverables
- Complete documentation of laboratory procedures (SOPs), 100% QC of data
Our Biosafety practices enable us to provide genomics services for early R&D to market release studies for pathogens that require BSL-2+ facilities.
- Dedicated BSL-2+ Lab and preamplification room for your clinical and genomics studies
- UNIDIRECTIONAL workflow from sample prep room to preamplification room to the instrument
- Trained personnel to handle BSL-2+ level agents
- Higher levels of lab safety for antimicrobial, human and animal health vaccine development
Security and Data Protection
MOgene considers safety and confidentiality a top priority for our client’s data.
- Individually coded key access to labs
- 24/7/365 temperature and humidity monitoring
- Daily data back-up
- Limited access to data files